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Anti-metabolites

Cladribine After Natalizumab for Multiple Sclerosis

Phase 4

Waitlist Available

Led By Olaf Stuve, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects of childbearing potential must use effective methods of contraception to prevent pregnancy for 4 weeks before initiation of cladribine tablets and must agree to continue to practice adequate contraception for at least 6 months after the last dose

Female subjects must not be pregnant or lactating at least 10 days after the last dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will assess the safety and efficacy of the drug cladribine after treatment with natalizumab in patients with RRMS and active SPMS.

Who is the study for?

This trial is for adults aged 18-60 with relapsing forms of Multiple Sclerosis, including RRMS and active SPMS, who have been on natalizumab therapy for at least a year. Participants must weigh over 40 kg, not be pregnant or breastfeeding, use contraception effectively, and have no recent MS relapses. Exclusions include HIV or hepatitis infection, TB history, immunocompromised status, certain prior treatments like myelosuppressives or live vaccines recently.Check my eligibility

What is being tested?

The study tests the safety and effects of cladribine tablets in patients previously treated with natalizumab. It aims to understand how cladribine impacts the disease's progression and immune response in those with Multiple Sclerosis after switching from another treatment.See study design

What are the potential side effects?

Potential side effects of cladribine may include lowered blood cell counts leading to increased infection risk; allergic reactions; possible kidney issues that prevent using contrast agents like gadolinium for MRI scans; hypersensitivity reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using effective birth control and will continue for 6 months after my last dose.

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I am not pregnant or breastfeeding.

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I have been diagnosed with a relapsing form of MS.

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I have been on natalizumab (300 mg daily) for at least 12 months.

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I understand and can follow the study's requirements.

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I haven't had any relapses in the last 28 days.

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I will use a condom for six months after my last dose, or my partner will use contraception.

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I weigh at least 40 kilograms.

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I am between 18 and 60 years old.

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I can walk without aid or rest for at least 200 meters.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute and percent change of T cells, B cells, DC subset and NfL levels in blood.

Secondary outcome measures

Annualized Relapse Rate (ARR)

Other outcome measures

Magnetic Resonance imaging (MRI) outcomes

The Expanded Disability Status Scale : Neurological disability outcome

Side effects data

From 2011 Phase 3 trial • 867 Patients • NCT00641537

24%

Back pain

20%

Neutropenia

12%

Hyperthermia

12%

Lymphopenia

12%

Influenza like illness

12%

Fatigue

12%

Influenza

Weight decreased

Hypertension

Anxiety

Uterine leiomyoma

Respiratory tract infection viral

Joint swelling

Anaemia of pregnancy

Viral upper respiratory tract infection

Skin bacterial infection

Dizziness

Viral infection

Arthralgia

Infected insect bite

Sinusitis

Carpal tunnel syndrome

Depressed mood

Pharyngolaryngeal pain

Cough

Joint sprain

Eye irritation

Upper respiratory tract infection

Headache

Depression

Restless legs syndrome

Pain in extremity

Eye pruritus

Contusion

Gastrooesophageal reflux disease

Hypersensitivity

Pregnancy

Herpes zoster

Liver function test abnormal

Abortion threatened

Iron deficiency anaemia

Erythema infectiosum

Tooth disorder

Faecal incontinence

Injection site abscess

White blood cell count decreased

Sensation of heaviness

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cladribine 3.5 mg/kg/No Treatment

Cladribine 5.25 mg/kg/No Treatment

Cladribine Low/Placebo (LLPP)

Cladribine High Dose/Placebo (HLPP)

Cladribine Low/Low Dose (LLLL)

Cladribine High/Low Dose (HLLL)

Placebo/Cladribine Low Dose (PPLL)

Placebo/No Treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: CladribineExperimental Treatment1 Intervention

All study participants will receive treatment with cladribine 10 mg tablets at the recommended cumulative dose of 3.5 mg/kg, divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). This regimen corresponds to the recommended dosage as per the USPI. Each treatment course is divided into 2 treatment cycles: Administration of first treatment course (year 1 treatment): First cycle: Starts on Day 1 of the study Second cycle: Administered 23 to 27 days after the last dose of first cycle. Administration of second treatment course (year 2 treatment): First cycle: Administered at least 43 weeks after the last dose of year 1 treatment Second cycle: Administered 23 to 27 days after the last dose of first cycle of year 2 treatment. The cycle dosage will be administered as 1 or 2 cladribine 10 mg tablets daily over 4 or 5 consecutive days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cladribine

2014

Completed Phase 4

~4390

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,759 Total Patients Enrolled

15 Trials studying Multiple Sclerosis

51,634 Patients Enrolled for Multiple Sclerosis

EMD SeronoIndustry Sponsor

143 Previous Clinical Trials

27,161 Total Patients Enrolled

36 Trials studying Multiple Sclerosis

11,250 Patients Enrolled for Multiple Sclerosis

Olaf Stuve, MD, PhDPrincipal Investigator - UT Southwestern Medical Center

University of Texas Southwestern Medical Center

Media Library

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04178005 — Phase 4

Multiple Sclerosis Research Study Groups: Cladribine

Multiple Sclerosis Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT04178005 — Phase 4

Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04178005 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Under what circumstances would this medicinal intervention be prescribed?

"This therapeutic intervention is utilized to address ctage1 protein in human patients. Furthermore, it can be effective at treating hairy cell leukemia, multiple sclerosis, and certain imaging diagnostics."

Answered by AI

What evidence is there to support the safety of this treatment for patients?

"This treatment has been verified, so it is assigned a score of 3 on our safety scale at Power. This rating reflects the fact that this drug is already approved and in Phase 4 trials."

Answered by AI

What is the enrollment capacity for this medical experiment?

"Unfortunately, this clinical trial is not accepting participants at the moment. It was first listed on February 19th 2020 and updated most recently on September 30th 2022. If you are interested in participating in a medical study for MS, there are currently 390 others recruiting with 34 trials specifically pertaining to this treatment."

Answered by AI

Are there precedents of research done on this particular therapeutic approach?

"Currently, the treatment is being investigated in 34 active studies with 7 trials at Phase 3. Houston, Texas serves as a main hub for these investigations and 359 medical sites are participating in relevant clinical experiments."

Answered by AI

Is there an age restriction for enrollment in this trial?

"Eligibility for this medical experiment is restricted to individuals between the ages of 18 and 60. Patients under 18 are able to enroll in 29 different clinical trials, while those over 65 may join 270 such initiatives."

Answered by AI

Is it possible to partake in this medical experiment?

"This medical trial seeks 40 volunteers that have been diagnosed with Multiple sclerosis and are aged 18 to 60. Male participants must use a condom throughout the study duration, while female enrollees need an additional form of contraception like an intra-uterine device or hormonal options such as implants, injectables, patches or oral contraceptives for the same amount of time. Other requirements include having EDSS between 0 and 5.5; 12 months continuous natalizumab therapy (300 mg/d); no relapses in last 28 days; weighing at least 40 kilograms; not being pregnant nor lactating 10 days after completion of treatment; and understanding"

Answered by AI

Is the enrollment process still open for this investigation?

"Unfortunately, the recruitment window for this trial has closed and it was last edited on September 30th 2022. Nevertheless, there are other opportunities available as 390 clinical trials with relevance to multiple sclerosis currently require participants and 34 studies related to this treatment also need volunteers."

Answered by AI

Recent research and studies

The Journal of ImmunologyJournal

Natalizumab for Multiple Sclerosis: A Case in Point for the Impact of Translational Neuroimmunology

Shirani, Afsaneh, and Olaf Stüve. 2017. “Natalizumab for Multiple Sclerosis: A Case in Point for the Impact of Translational Neuroimmunology”. The Journal of Immunology. The American Association of Immunologists. doi:10.4049/jimmunol.1601358.

Multiple Sclerosis JournalJournal

Does Risk Stratification Decrease the Risk of Natalizumab-associated PML? Where Is the Evidence?

Cutter, Gary R, and Olaf Stüve. 2014. “Does Risk Stratification Decrease the Risk of Natalizumab-associated PML? Where Is the Evidence?”. Multiple Sclerosis Journal. SAGE Publications. doi:10.1177/1352458514531843.

Proceedings of the National Academy of SciencesJournal

Lymphospecific Toxicity in Adenosine Deaminase Deficiency and Purine Nucleoside Phosphorylase Deficiency: Possible Role of Nucleoside Kinase(s)

Carson, Dennis A., Jonathan Kaye, and J. E. Seegmiller. 1977. “Lymphospecific Toxicity in Adenosine Deaminase Deficiency and Purine Nucleoside Phosphorylase Deficiency: Possible Role of Nucleoside Kinase(s)”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.74.12.5677.

Current Medical Research and OpinionJournal